Risperidone and Suicidality in Major Depressive Disorder

Depression Clinical Trial

Official title:

Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167154
• Other study ID #: F030929002
• Secondary ID: RIS-DED-402
• Status: Completed
• Phase: Phase 3
• Start date: June 2004
• Est. completion date: August 2008

Study information

• Verified date: June 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder.

Description:

Using a double blind, placebo-controlled design, subjects diagnosed with a current episode of major depressive disorder (defined by DSM-IV criteria and supported by the Mini International Neuropsychiatric Interview), severe with suicidality despite currently taking an antidepressant, will be enrolled in the eight-week study. The treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking. The clinical efficacy will be evaluated after 4 days, weekly for 4 weeks, then every other week for 4 weeks with the efficacy measures. During the eight-week study, treatment with risperidone or placebo will continue at the highest effective dosage (up to 2 mg per day). The dose of the antidepressant will not be changed during the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

1. 19-60 years of age

2. Diagnosis of major depressive disorder, currently severe with suicidality

3. A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4

4. Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks

5. In good physical health

Exclusion Criteria:

1. Depression without suicidality

2. Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)

3. Depressive symptoms induced by alcohol or substance abuse

4. Psychotic features which are predominant at the initial evaluation

5. Unstable major medical illness, such as cardiac disease or diabetes

6. Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Risperidone and placebo comparator
Up to 2 mg risperidone or matching placebo daily

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Janssen Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Reeves H, Batra S, May RS, Zhang R, Dahl DC, Li X. Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. J Clin Psychiatry. 2008 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGI	Clinical Global Impression	8 weeks
Secondary	MADRS	Montgomery Asberg Depression Rating Scale	8 weeks